SCHEDULES

SCHEDULE 11Advice and representations

PART 2Type II variation applications, complex variation applications and new excipient variation applications

Application of this Part

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This Part applies—

a

to an application (a “Type II variation application”) to vary a UK marketing authorisation if the variation is a major variation of Type II within the meaning of Article 2(3) of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products M1F1or paragraph 1 of Schedule 10A; and

b

to an application to vary a traditional herbal registration that is—

i

a complex variation application, or

ii

a new excipient variation application.